EPA admits to Court: Human subjects ‘may die’ from air pollution experiments

Posted on October 5, 2012 by Steve Milloy | 9 Comments  This first appeared here.  RK

EPA has admitted to a federal court that it asks human guinea pigs to sacrifice their lives for regulatory purposes — and $12 per hour.

EPA has responded to our emergency motion for a temporary restraining order (TRO) against its ongoing human experiment (called “CAPTAIN”) involving the air pollutant known as PM_2.5.

In the declaration of Martin W. Case, the EPA clinical research studies coordinator for CAPTAIN, Case claims he verbally warns study subjects before the experiment as follows:

… My first approach after being introduced to the subject by the medical station staff is to ask the subject if they have read the consent form. The subjects for CAPTAIN have been given the informed study consent form on a previous visit, and, they are also given the same consent to read again if they have not read the consent the day of the training…
I provide participants with information about fine particles (PM2.s). I say that PM2.s are particles so small that they are able past through your airways and go deep into your lungs, these particles are so small that your usual lining and cilia of your airways are not able to prevent these particles from passing into your lungs, Therefore, if you are a person that for example lives in a large city like Los Angeles or New York, and it’s been a very hot day, and you can see the haze in the air, and you happen to be someone that works outside, and if you have an underlying unknown health condition, or, you may be older in age; the chances are that you could end up in the emergency room later on that night, wondering what’s wrong, possibly having cardiac changes that could lead to a heart attack; there is the possibility you may die from this…

Here’s the analysis of Case’s remarkable admission — that is, if we can even rely on Case’s declaration:

1. Prohibition on human sacrifice. Every law, regulation and code developed since World War II strictly prohibits human sacrifice (i.e.,significant injury or death) for no health benefit to the patient (the wage of $12 per hour does not count as a “benefit”). EPA employee Case explicitly admits in this declaration that short-term exposure to PM_2.5can be lethal.And though Case attempts to distance this warning from the experiment by explaining the risk in terms of a person living “in a large city like Los Angeles or New York”, EPA states in its IRB application for approval of CAPTAIN, “The particle burden, on a mass basis presented to the volunteer will not exceed an exposure an individual receives over a 24 hour period while visiting a typical urban center in America on a smoggy day.” Moreover, EPA has repeatedly stated in numerous regulatory documents and public statements that there is no safe level of exposure to PM_2.5 and that any exposure to PM_2.5 can kill within hours or days.
2. Failure to obtain substantive informed consent. Despite Case’s admission that experimental exposure to PM_2.5 may cause death, according to the EPA-provided consent form given to study subjects, the risks of experimental exposure to PM_2.5 are only as follows:

   PM exposure: During the exposure to the concentrated air pollution particles, you may experience some minor degree of airway irritation, cough, and shortness of breath or wheezing. These symptoms typically disappear 2 to 4 hours after exposure, but may last longer for particularly sensitive people. You will be monitored continuously during the exposure session through a window in the chamber or by closed-circuit television, and can communicate with a staff member via an intercom. Your heart rate and rhythm will also be constantly monitored for any adverse changes brought about by the exposure. In the unlikely event that you develop medically significant symptoms, the exposure will be terminated and the appropriate medical intervention will be provided if required. A physician is always available on the premises to respond to an emergency and full resuscitation equipment is available for use in the event of a cardiac or pulmonary emergency.
   Air pollution particles may induce an inflammatory reaction that can last for 24 hours after exposure and may increase the chance of you catching a cold. You should not engage in heavy levels of exercise for 24 hours before and after the exposure period. If you have any tendency to become uncomfortable in small closed spaces, it is possible that you may become uncomfortable during the chamber exposure. Although the chamber is somewhat small, it has multiple windows and you will be in constant visual contact with the investigator who will be monitoring you during the exposure. You also will be able to verbally communicate with the investigator via a microphone headset.

   So in the place in the consent form where EPA is legally required to disclose to study subjects all the risks the experiment entails, EPA omits death, as well as all the dangers it mentioned to the institutional review board in the IRB application, including:
   

   Numerous epidemiological studies have demonstrated an association between acute and chronic exposure to ambient levels of particulate matter (PM) and various adverse cardiopulmonary effects including mortality, respiratory tract infection, exacerbation of asthma, chronic bronchitis, ischemic heart disease, and stroke (see review, (1)). A recent national scale epidemiological study has shown that short-term exposure to particulate matter (PM) is associated with increased rates of hospital admission for cardiovascular and respiratory symptoms. The cardiovascular risk tended to be higher in the Eastern United States. This study also indicated a disproportionate risk among the elderly who are exposed to PM (2). Dietary factors such as intake of omega-3 fatty acids have been linked to human susceptibility to the adverse effects of ambient PM (14).Although air pollution exposure has long been known to be a risk factor for respiratory disease, over the last decade, a growing body of epidemiological studies has heightened concern over elevated rates of cardiovascular events related to both short-term and long-term exposure to PM (3). The risk of death from cardiovascular disease (myocardial infarction, heart failure, and fatal arrhythmias) in response to chronically high levels of air pollution was much greater than that from lung disease (4-6). Short-term elevations in ambient PM levels are capable of evoking cardiac arrhythmias, worsening heart failure, and triggering acute atherosclerotic/ischemic cardiovascular complications, particularly in certain at-risk subsets of population (3). PM exposure can result in increases in heart rate, and decreases in heart rate variability (HRV; defined as changes in mean heart rate during 24 hrs, which is a reflection of autonomic tone on the heart (7). PM has been associated with transient increases in plasma viscosity (8), endothelial dysfunction (9) and acute-phase reactants (10, 11) such as C-reactive protein (12). Animal studies have suggested that long-term exposure to low concentration of PM altered vasomotor tone, induces vascular inflammation and potentiates atherosclerosis (13). Despite a decade of intensive studies, much about the PM health effects problem, especially the cardiovascular effect, is still not well understood. The present study is designed to test the hypothesis that genetic expression of the Phase II metabolizing enzyme GSTM1 alters the outcome of adverse responses
   to PM exposure.

3. Failure to provide/obtain written consent. The Common Rule, as codified in federal regulation 40 CFR 26.117, specifically requires that written informed consent be obtained when risk of serious injury or death is involved in an experiment. As the consent form provided by EPA makes no mention of the risk of death, written consent acknowledging that they are willing sacrifice themselves for EPA regulatory purposes is not obtained.